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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic
510(k) Number K843953
Device Name SCANHEADS ACCESS 10 10PV B10
Applicant
Advanced Technology Laboratories, Inc.
P.O. Box 6639
Bellevue,  WA  98008
Applicant Contact FRANCIS G SMITH
Correspondent
Advanced Technology Laboratories, Inc.
P.O. Box 6639
Bellevue,  WA  98008
Correspondent Contact FRANCIS G SMITH
Regulation Number870.2880
Classification Product Code
JOP  
Date Received10/09/1984
Decision Date 03/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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